8 Pharmaceutical Quality Assurance Specialist jobs in whatjobs
Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Pharmaceutical Quality Assurance Specialist
Posted 11 days ago
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Pharmaceutical Quality Assurance Specialist
Posted 10 days ago
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The Pharmaceutical Quality Assurance Specialist will be responsible for developing, implementing, and maintaining quality systems and procedures. This includes conducting internal audits, reviewing documentation, investigating deviations, and ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations. The ideal candidate possesses a strong scientific background, a keen eye for detail, and a comprehensive understanding of pharmaceutical quality assurance principles.
Key responsibilities include:
- Developing, implementing, and maintaining quality assurance policies and procedures.
- Ensuring compliance with all relevant pharmaceutical regulations, including GMP, FDA, and other regulatory bodies.
- Conducting internal audits of manufacturing processes, documentation, and facilities.
- Reviewing and approving batch records, validation reports, and other critical quality documents.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
- Participating in external audits by regulatory agencies and customers.
- Managing the change control process to ensure that changes to processes, equipment, or materials are properly evaluated and documented.
- Monitoring quality metrics and key performance indicators (KPIs) to identify trends and areas for improvement.
- Providing training to personnel on quality assurance procedures and GMP principles.
- Collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs.
- Staying up-to-date with evolving regulatory requirements and industry best practices.
- Contributing to the continuous improvement of the Quality Management System (QMS).
- Maintaining accurate and organized quality records.
The ideal candidate will have a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A minimum of 4 years of experience in pharmaceutical quality assurance is required. Strong knowledge of GMP, regulatory guidelines, and quality control principles is essential. Excellent analytical, problem-solving, and documentation skills are a must. Proficiency in quality management software and Microsoft Office Suite is expected. The ability to work independently and collaboratively in a remote setting is crucial. This is an impactful role contributing to health and safety. The role is associated with **Kericho, Kericho, KE**, but is fully remote.
Pharmaceutical Quality Assurance Specialist
Posted 6 days ago
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Key responsibilities include developing, implementing, and maintaining quality assurance programs and procedures. You will conduct internal audits, review batch records, manage deviations and change controls, and participate in regulatory inspections. The role involves collaborating with various departments, including R&D, manufacturing, and quality control, to ensure seamless integration of quality into all processes. Experience in quality risk management and CAPA (Corrective and Preventive Actions) implementation is essential. You will play a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. This position demands exceptional analytical skills, strong problem-solving capabilities, and a commitment to continuous improvement. The ability to interpret complex regulations and apply them effectively in a practical setting is paramount. You will contribute significantly to maintaining our client's reputation for excellence and compliance. This is a key role located within our facilities at Kitale, Trans-Nzoia, KE .
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal audits and inspections to ensure compliance with GMP and regulatory standards.
- Review and approve batch records, specifications, and validation documents.
- Manage deviations, out-of-specification (OOS) results, and change control processes.
- Participate in external audits and inspections by regulatory authorities.
- Collaborate with manufacturing, R&D, and QC departments to resolve quality issues.
- Implement CAPA (Corrective and Preventive Actions) to address quality deficiencies.
- Stay up-to-date with relevant pharmaceutical regulations and industry best practices.
- Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
- 3+ years of experience in pharmaceutical quality assurance or quality control.
- Thorough understanding of GMP, ISO standards, and regulatory requirements (e.g., FDA, EMA).
- Experience with QMS, audits, deviation management, and CAPA.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
Pharmaceutical Quality Assurance Specialist
Posted 15 days ago
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Pharmaceutical Quality Assurance Specialist
Posted 16 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and maintain quality management systems (QMS) in compliance with relevant pharmaceutical regulations (e.g., FDA, EMA).
- Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
- Review and approve batch manufacturing records (BMRs) and analytical testing data.
- Manage and investigate deviations, out-of-specification (OOS) results, and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPAs).
- Participate in external audits by regulatory agencies and customers.
- Oversee validation and qualification activities for equipment, processes, and systems.
- Develop and deliver quality training programs for relevant personnel.
- Stay updated on evolving pharmaceutical quality standards and regulatory changes.
- Contribute to risk management activities and process improvements.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is a plus.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
- Thorough understanding of GMP guidelines, ICH guidelines, and other relevant regulatory requirements.
- Experience with quality systems, batch record review, deviation management, and CAPA implementation.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and accuracy.
- Proficient in using quality management software and standard office applications.
- Effective written and verbal communication skills.
- Ability to work independently and manage multiple tasks in a remote setting.
- Experience with audits (internal and external) is highly desirable.
Pharmaceutical Quality Assurance Specialist
Posted 5 days ago
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Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS).
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
- Conduct internal audits of manufacturing processes, facilities, and documentation.
- Review and approve batch records, validation protocols, and reports.
- Investigate deviations, non-conformances, and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPAs).
- Participate in external audits by regulatory agencies and customers.
- Manage and maintain quality-related documentation and records.
- Provide training to personnel on quality assurance procedures and GMP principles.
- Collaborate with production, R&D, and other departments to resolve quality issues.
- Stay updated on changes in pharmaceutical regulations and quality standards.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, ISO standards, and pharmaceutical regulatory requirements.
- Experience with quality control testing, batch record review, and deviation management.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent attention to detail and organizational abilities.
- Proficiency in Microsoft Office Suite and quality management software.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a collaborative team.
- Pharmaceutical industry certifications are a plus.
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Pharmaceutical Quality Assurance Specialist
Posted 4 days ago
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Key Responsibilities:
- Develop, implement, and maintain quality assurance systems and procedures in compliance with GMP, ICH, and other relevant regulatory guidelines.
- Conduct internal audits and inspections of manufacturing processes, facilities, and documentation to ensure compliance.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in the qualification and validation of equipment, processes, and analytical methods.
- Manage change control processes, assessing the impact of changes on product quality.
- Prepare for and participate in regulatory inspections by health authorities (e.g., PPB, FDA, EMA).
- Train manufacturing personnel on quality systems and GMP principles.
- Monitor quality metrics and key performance indicators (KPIs), reporting findings to management.
- Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to resolve quality issues.
- Contribute to the continuous improvement of quality systems and processes.
- Maintain accurate and organized quality records.
- Stay updated on current regulatory requirements and industry best practices.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is a plus.
- Minimum of 3-5 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, GDP, and other pharmaceutical quality standards.
- Experience with regulatory inspections and submissions.
- Strong understanding of manufacturing processes, validation, and documentation control.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in using quality management software and standard office applications.
- Strong written and verbal communication skills.
- Ability to work effectively both independently and as part of a team.
- Meticulous attention to detail and a commitment to accuracy.
- Experience with audits and CAPA management.
This hybrid role offers a blend of remote flexibility and on-site engagement, allowing you to contribute significantly to our quality-centric operations. If you are a dedicated QA professional with a passion for ensuring product excellence in the pharmaceutical sector, we encourage you to apply.